BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073483 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01196
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 5ML YELLOW TOP SERUM TUBE AND CENTRIFUGED AT 3200 RPM FOR 10 MINUTES. SAMPLE WAS STORED FROZEN BETWEEN OBTAINING THE ORIGINAL RESULT AND THE REPEAT TESTING. BOTH LEVELS OF BHCG QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE PAST 30 DAYS. ROUTINE SYSTEM CHECKS PERFORMED ON (B)(6) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE REPLACED PRECISION PUMP. FSE PERFORMED A 20 REPLICATE PRECISION TEST USING ASSAY QC. RESULTS WERE WITHIN THE EXPECTED PRECISION OF THE ASSAY. FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE ACCESS 2 IMMUNOASSAY SYSTEM GENERATED LOWER THAN EXPECTED POSITIVE BHCG RESULTS FOR ONE (1) PATIENT THAT DID NOT MATCH THE ORIGINAL RESULT. SUBSEQUENT TESTING ON AN ALTERNATIVE METHODOLOGY PRODUCED A HIGHER POSITIVE RESULT THAT BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION AND THE PATIENT'S ORIGINAL RESULT. RESULTS ARE SHOWN. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR